Shared Decision-Making Tool for Opioid Prescribing After Ambulatory Hand Surgery in Veterans
1 other identifier
interventional
60
1 country
1
Brief Summary
The purpose of this study is to determine if an educational patient-centered presentation reduced the amount of opioid pills requested and utilized by patients compared to standard of care group.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Nov 2018
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 9, 2018
CompletedFirst Submitted
Initial submission to the registry
November 6, 2020
CompletedFirst Posted
Study publicly available on registry
November 12, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
May 30, 2022
CompletedAugust 12, 2022
August 1, 2022
3.5 years
November 6, 2020
August 11, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Number of Opioid Pills Dispensed
1 day (Once after surgery)
Number of Opioid Pills Consumed
4 weeks
Secondary Outcomes (2)
Patient-Reported Outcomes Measurement Information System Pain Interference Score
Once a week for 4 weeks after surgery
Patient-Reported Outcomes Measurement Information System Pain Intensity Score
Once a week for 4 weeks after surgery
Study Arms (2)
Shared-Decision Making Tool Group
EXPERIMENTALStandard of Care Group
NO INTERVENTIONInterventions
Patients received a short video presentation on pain management, use of over the counter medication, side effects of opioids and over-the-counter medications and ability to choose the amount of opioid pills up to the standard care amount.
Eligibility Criteria
You may qualify if:
- a. 18-89 years of age
- b. Patient at the Orthopedic Department at the Veterans Health Administration
- c. Indicated for upper extremity surgeries: E.g., Carpal Tunnel Release, Trigger Finger Release, Cubital Tunnel Release, Ganglion Cyst Excision
You may not qualify if:
- a. History of opioid use disorder
- b. Had any recent surgery within four weeks of upper extremity procedure
- c. Taking opioids prior to surgery
- d. Returning to an institutionalized setting
- e. Pregnancy
- f. Unable to communicate in the English language
- g. Allergy to any medication recommended for post-operative analgesia
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Rocky Mountain Regional VA Medical Center
Aurora, Colorado, 80045, United States
Study Officials
- PRINCIPAL INVESTIGATOR
Rajshri Bolson, MD
Rocky Mountain Regional VA Medical Center
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Masking Details
- Both patients and investigators were blinded to group assignment until an envelope was opened after the patient consented.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 6, 2020
First Posted
November 12, 2020
Study Start
November 9, 2018
Primary Completion
May 1, 2022
Study Completion
May 30, 2022
Last Updated
August 12, 2022
Record last verified: 2022-08
Data Sharing
- IPD Sharing
- Will not share